48 Participants Needed

Virtual Reality Mindfulness Meditation for ACL Injury

SE
Overseen ByShelby E Baez, Ph.D., ATC
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if using virtual reality for mindfulness meditation can help women who had ACL surgery reduce their fear of injury, improve their movements, and enhance brain activity. The study compares this method to another VR experience over a period of time. Virtual Reality (VR) has been increasingly used to enhance mindfulness practices, showing benefits in mental health and engagement.

Will I have to stop taking my current medications?

The trial requires that participants not be on any medication that affects the central nervous system.

Is Virtual Reality Mindfulness Meditation safe for humans?

Research on Virtual Reality Mindfulness Meditation shows it is generally safe, with mild side effects like VR sickness (feeling dizzy or nauseous) reported in some cases. Studies involving people with PTSD, chronic pain, and psychosis found no major safety concerns, suggesting it is a safe option for various conditions.12345

How does Virtual Reality Mindfulness Meditation treatment differ from other treatments for ACL injury?

Virtual Reality Mindfulness Meditation is unique because it uses immersive technology to deliver mindfulness practices, which can improve mood and reduce stress, potentially enhancing recovery from ACL injuries. Unlike traditional physical therapies, this approach leverages VR to create an engaging and accessible environment for mindfulness, which may also help manage pain and emotional well-being.23678

What data supports the effectiveness of the treatment Virtual Reality Mindfulness Meditation for ACL Injury?

Research shows that virtual reality can help reduce anxiety and pain in medical settings, such as during orthopedic procedures and preoperative situations. Additionally, using virtual reality for mindfulness training has been effective in reducing negative emotions and anxiety in patients with spinal cord injuries.69101112

Who Is on the Research Team?

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Shelby E Baez, Ph.D., ATC

Principal Investigator

UNC-Chapel Hill

Are You a Good Fit for This Trial?

This trial is for females aged 14-25 who had left-side ACL reconstruction surgery 1 to 5 years ago, are right-hand dominant, and injured their knee in sports. They must have MRI compliance, specific levels of fear related to movement (measured by a special scale), and poor jump-landing patterns. Excluded are males, those with recent concussions or CNS medications, claustrophobia, metal implants that can't be removed, under drug influence or pregnant.

Inclusion Criteria

Injured their knee playing or training for sports (recreational or organized)
I have had ACL reconstruction surgery on my left knee.
Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11
See 6 more

Exclusion Criteria

Presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed
I have a neurological condition like epilepsy.
Pregnancy or suspicion of pregnancy
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of virtual reality mindfulness meditation or sham intervention along with an advanced neuromuscular training program

8 weeks
Weekly sessions

Follow-up

Participants are monitored for changes in injury-related fear, jump-landing movement patterns, and brain activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Reality Mindfulness Meditation
  • Virtual Reality Sham
Trial Overview The study tests if virtual reality mindfulness meditation helps reduce injury-related fear, improves jump-landing movements and brain activity after ACL surgery compared to a sham VR experience. Participants will be divided into two groups: one experiencing the meditation VR and the other a fake version.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VR Mindfulness Meditation GroupExperimental Treatment1 Intervention
Participants will complete 8-weeks of virtual reality mindfulness meditation and an advanced neuromuscular training program. Mindfulness meditation is the practice of sustaining attention on the body, breath, or sensations in any given moment and allows for the self-regulation of attention by decreasing rumination about past or future events. During the practice of mindfulness meditation, the individual is aware of all incoming thoughts and feelings, but rather than reacting to them, the individual accepts them. Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional mindfulness meditation. Use of a virtual reality system to implement mindfulness meditation not only decreases the barrier of time to implement psychological interventions, but also improves the clinician's confidence in implementing the intervention as the virtual reality system guides the patient through the mindfulness meditation process.
Group II: VR Sham GroupPlacebo Group1 Intervention
Participants will complete 8-weeks of virtual reality sham and an advanced neuromuscular training program. Participants will be immersed in a virtual environment but will not receive the mindfulness meditation.

Virtual Reality Mindfulness Meditation is already approved in United States for the following indications:

🇺🇸
Approved in United States as Virtual Reality Mindfulness Meditation for:
  • Reduction of injury-related fear after ACL reconstruction
  • Improvement of jump-landing movement patterns after ACL reconstruction
  • Improvement of brain activity after ACL reconstruction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Published Research Related to This Trial

In a randomized controlled trial involving 20 first-time sternotomy patients, immersive virtual reality (VR) treatment significantly reduced anxiety levels compared to a tablet-based control, with VR users reporting feeling calmer and less tense (P<0.05).
The study demonstrates that VR is an effective nonpharmacologic method for alleviating preoperative anxiety in adults undergoing cardiac surgery, highlighting its potential utility in clinical settings.
The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial.Hendricks, TM., Gutierrez, CN., Stulak, JM., et al.[2020]
The study demonstrated that Immersive Virtual Reality (VR) enhanced Dialectical Behavioral Therapy (DBT) Mindfulness skills training can help reduce negative emotions and anxiety in two patients with spinal cord injuries, with one patient showing significant reductions in ASD/PTSD symptoms after just one session.
Both patients found the VR experience enjoyable and were able to use the equipment with assistance, indicating the feasibility of this therapeutic approach for individuals with paralysis.
The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study.Flores, A., Linehan, MM., Todd, SR., et al.[2020]
Patients who experienced a preoperative virtual reality (VR) session with 3D MRI models of their knee reported significantly lower anxiety levels compared to those who received standard information, as measured by the Amsterdam Preoperative Anxiety and Information Scale.
The VR group also showed higher satisfaction and lower stress levels postoperatively, indicating that VR can enhance the overall patient experience before and after arthroscopic knee surgery, although it did not impact pain or preparedness.
Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study.Yang, JH., Ryu, JJ., Nam, E., et al.[2020]

Citations

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. [2020]
The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study. [2020]
Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. [2020]
Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]
Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. [2021]
Meditating in virtual reality: Proof-of-concept intervention for posttraumatic stress. [2021]
The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. [2022]
Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. [2023]
Effects and safety of virtual reality-based mindfulness in patients with psychosis: a randomized controlled pilot study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. [2022]
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